FDA MedWatch Program
Reporting Adverse Drug Reactions
MedWatch is an FDA program for reporting "serious reactions" resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:
- Patient's Death: when adverse reaction to drug is the suspected cause of death
- Life-Threatening Condition: serious side-effect put patient at real risk of dying
- Hospitalization: admitted because of serious adverse reaction to medication
- Permanent Disability: strokes; nervous system disorders; other impairment
- Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to child
- Needs Medical Intervention to Avoid Permanent Damage: medical treatment required
There are several different ways to file a MedWatch report with the FDA. We provide some basic information about how to file a MedWatch report on this site.
If you are interested in getting the facts of your possible drug injury claim reviewed by our law firm, click here for a free legal case evaluation.